Dr. Lin
CMC Principal Consultant
Ex-FDA Small Molecule CMC senior reviewer

Dr. Lin received a BA in Biochemistry and a PhD in Organic Chemistry. From 1996-2004, he was a CMC Reviewer, Team Leader, and Deputy Division Director in the CDER, FDA. As a CMC Reviewer, Dr. Lin was responsible for the comprehensive review of CMC data for drugs being investigated during Phase 1, 2, and 3 clinical studies. This included providing scientific and regulatory guidance during the development of small molecular weight drugs, antibody (peptide)-drug conjugates, and biotechnological/biological drugs across a wide variety of dosage forms for the therapeutic treatment of reproductive and urologic indications. Dr. Lin reviewed CMC data submitted to over 100 INDs and NDAs, contributed to decisions regarding the approval of drugs, made presentations before scientific and regulatory conferences, and participated in a variety of special FDA projects and committees, including serving as the Chair of the Stability Guidance Technical Committee.

Expertise:

• The development of mRNA products for use as vaccines and therapeutics in FDA/CBER.  The focus has been on the manufacturing of these products and the characterization to support the IND. 
• On therapeutic drug development side, similar synthetic molecules include oligonucleotides reviewed in FDA/CDER.
• Global CMC development planning for drugs and biotechnological/biological drugs.
• Designing CMC protocols and other documents which are compliant with FDA regulations and expectations.
• Assisting clients in the development of analytical methodology and design of stability testing protocols.
• Representing clients in interactions with the FDA.
• Assisting clients in preparing for FDA meetings.
• Assisting clients in writing CMC sections of pre-IND, IND and NDA submissions.
• Providing clients with a comprehensive “FDA style” review of IND and NDA CMC submissions

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